Using Validat 5 (iCD) with Clarity

Significance of the topic

The integration of chromatographic data acquisition software with validation tools ensures robust compliance with international guidelines, enhances data integrity, and streamlines method validation workflows.

Study objectives and overview

This document outlines the configuration and use of the interface between Validat 5 software and Chromatography Station 3.0 or later to facilitate method validation in line with guidelines such as DIN, USP and ICH. It covers setup steps, data exchange processes and practical tips for bidirectional communication.

Applied methodology and instrumentation

Integration relies on the Clarity Interface extension within Validat 5 which communicates via import and export directories. The main components include:

• Validat 5 software with Clarity Interface extension
• Clarity Chromatography Station 3.0 or newer
• Configured file directories for data exchange

Main results and discussion

The interface enables four key workflows:

• Connection test and directory creation: automatic setup of import and export folders for reliable file transfer.
• Method import: association of Validat projects with Clarity methods, generating sequence files that link directly to validation protocols.
• Sequence export: creation of worklists within Validat, producing TXT sequence files compatible with Clarity for sample analysis.
• Result import: automated retrieval of summary tables from Clarity runs into Validat for further processing.

Successful execution of these steps demonstrates seamless exchange of method definitions, sequence data and analytical results, reducing manual intervention and error risk.

Benefits and practical applications

The combined system offers:

• Regulatory compliance through validated method exchange.
• Time savings by automating data transfers.
• Enhanced data integrity via consistent file formats and structured workflows.
• Flexibility to adapt existing methods across platforms.

Future trends and applications

Anticipated enhancements include support for all Clarity project directories, expanded metadata handling and real-time integration. Potential applications span high-throughput screening, automated quality control and integration with laboratory information management systems.

Conclusion

The Validat 5 and Clarity Interface integration provides a robust framework for method validation, offering streamlined workflows, minimized errors and full compliance with industry standards.

References

DataApex Validat 5 Clarity Interface Manual Code version D066 EN04 2022